Palbociclib
Approved · FDA / EMAAlso known as Ibrance, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one.
Recent clinical, regulatory, research and industry developments relating to this drug.
Molecular Analysis for Therapy Choice (MATCH)
PAveMenT: Phase Ib Study of Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer
Indication expansion: PALBOCICLIB (NDA207103)
Indication expansion: PALBOCICLIB (NDA212436)
Approval: Palbociclib Viatris (EMA)
Indication expansion: PALBOCICLIB (NDA207103)
The evolution of precision oncology: The ongoing impact of the Drug Rediscovery Protocol (DRUP).
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic… Show full indicationShow less
Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer. in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1). In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist.
Indication: Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer:… Show full indicationShow less
Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes3
Journals, researchers & institutions
- Annals of oncology : official journal of the European Society for Medical Oncology2
- The New England journal of medicine2
- Acta oncologica (Stockholm, Sweden)1
- BMC cancer1
- Cancer research1
- Drugs1
- DeMichele A4
- Im SA3
- Lu DR3
- Colleoni M2
- Cristofanilli M2
- Diéras V2
- Finn RS2
- Giorgetti C2
- University of Pennsylvania2
- Beth Israel Deaconess Medical Center1
- Brigham and Women's Hospital and Harvard Medical School1
- British Columbia Cancer Agency-Vancouver Centre1
- Dana-Farber Cancer Institute1
- David Geffen School of Medicine1
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Acts on the same molecular target as Palbociclib, with 2 overlapping disease areas.
Acts on the same molecular target as Palbociclib, with an overlapping disease area.
Studied across the same disease area as Palbociclib in the shared literature.
Studied across the same disease area as Palbociclib in the shared literature.
Studied across the same disease area as Palbociclib in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.